Biotech & Pharma·1 min read

Are Chinese biotech cycle times really crazy?

Biotech & Pharma

Ok, this is mysterious. Before drawing conclusions about the speed of exploration there vs. here, I would be grateful if someone could explain Elliot Hershberg's observation. I, too, read the preprint and found the following mind-blowing statement:

"The favorable preclinical outcomes observed in safety and efficacy studies using a GLP-grade Apt-circRNA-KR2 vaccine in rats and the NCG-M mouse model propelled momentum toward clinical translation. We therefore initiated a clinical trial at Zhejiang Xiaoshan Hospital to evaluate both the safety and early immune responses elicited by Apt-circRNA-KR2 in healthy volunteers."

Holy Moly! One GLP rat study and nice mouse model studies and there you go!!? For a novel approach!!? This would save a lot of crab-eating macaques (cynomolgus), not to mention a lot of time and money. Which leads to a ton of comments about how China is the place to explore and the US the place to confirm (and exploit). This narrative is quite compelling, except that when you dig into the Chinese regulatory requirements, you find pretty much the same, or sometimes even more stringent, demands for the Chinese equivalent of an IND, with no obvious exceptions for Chinese, China-based teams. So if someone could reconcile for me how what is described in that preprint is even possible, it would help. What am I missing?

Alex Zhavoronkov, Andrii Buvailo, Ph.D., Andrew Dunn, Simon Birksø Larsen